Destroy of the product demaged due to fire

Central Drugs Standard Control Organization © Directorate General of Health Services Ministry of Health & Family Welfare (Medical Devices Division) Food & Drugs Administration Bhawan, Kotla Road, New Dethi-110002 File No. 29/Misc./3/2014-DC (64) Date: * To M/s Wellmed international industries, Pvt. Ltd, A- 176 & 177, Sector — 63, Noida -201301 (U.P.) Subject: Damage of the product (IV cannula) due to fire manufactured by M/s Wellmed International industries, Pvt. Ltd, A-176 & 177, Sector -63, Noida, UP for export to Bangladesh - Reg. Sir, Please refer to your letter dated 23.06.2014 on the subject cited above. In this connection, the inspection of the incident site was carried out by the officials of CDSCO (EZ), Kolkata and State Licensing Authority (SLA), West Bengal. The inspection team observed that material was found stored in damaged conditions and was without legible Batch No., Mfg. & Exp. Date details etc. Further, details of incidence could not be ascertained from Bongaon Municipality. The inspection team concluded that quality and quantity of the material and actual cause of incidence cannot be ascertained. In view of above, you are directed to destroy the material as per your SOP and dispose off the material as per the provisions of Biomedical Waste Management Act and other applicable laws in presence of Drugs Inspector from SLA, WB in coordination with Bongaon Municipality. Yours faithfully, (Dr. G.N} Singh) Drugs Controller Géneral (1) Copy to: 1. Director, Drugs Control West Bengal, 141, A.J.C. Bose Road, CMS Building Kolkata- 700014 2. The Deputy Drugs Controller, CDSCO (East-Zone), C.G.O. Building, Nizam Place, 24 Floor, 234/4 A.J.C. Bose Road, Kolkata- 700020.